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The Pioneer Plus catheter is intended to facilitate placement and positioning of catheters within the peripheral vasculature. The Pioneer Plus catheter also provides an intraluminal cross-sectional ultrasound image of interest to facilitate placement of guidewires beyond stenotic lesions (e.g., sub-total, total occlusions) prior to additional intervention (i.e. PTA, stent, etc.). The Pioneer Plus catheter is not indicated for use in the coronary or cerebral vasculature.

The Pioneer Plus catheter is a dual lumen catheter that is inserted through a commercially available 6F introducer sheath and placed percutaneously into a peripheral vessel. The Pioneer Plus catheter tracks to its intended site in the vasculature over a standard, commercially available 0.014" (0.36 mm) tracking guidewire. The Pioneer Plus catheter utilizes an extendable, hollow Nitinol needle - minimum internal needle diameter: 0.016" (0.43 mm): it is compatible with floppy 0.014" (0.36 mm) over the wire (OTW) guidewires to facilitate the redirection and placement of the guidewire into peripheral vessels. The needle orientation placement is achieved through the use of an intravascular ultrasound (IVUS) transducer mounted at the distal end of the Pioneer Plus catheter. The Pioneer Plus catheter operator navigates the peripheral vasculature under fluoroscopic guidance and uses IVUS imaging to direct the needle to achieve optimal placement. The operator uses the Needle Deployment Ring incorporated into the handle of the Pioneer Plus catheter to extend the needle from the catheter. The needle can be extended up to 7mm in length, or to a pre-determined distance using the Stop Ring. A 0.014" (0.36 mm) OTW guidewire (needle guidewire) can then be advanced through the needle and used to facilitate the placement of subsequent catheters once the Pioneer Plus device is withdrawn.

The provided text describes an FDA 510(k) summary for a medical device called the "Pioneer Plus Catheter." The acceptance criteria and the study proving the device meets these criteria are outlined in the "PERFORMANCE DATA" section.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document states that "All testing met the acceptance criterial with 95/95 confidence/reliability."

2. Sample size used for the test set and the data provenance:

• Sample Size: The document does not explicitly state the sample size used for each specific test (e.g., number of catheters tested for Bend Radius). It only mentions that "Non-clinical device testing was conducted to confirm the performance of the modified device."
• Data Provenance: Not specified. The tests are described as "Bench testing," indicating they were performed in a lab setting, likely by the manufacturer (Philips Volcano). There is no information regarding country of origin of data, and it is inherently a prospective study as it's testing a modified device's performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The testing appears to be focused on engineering performance criteria rather than human interpretation or clinical outcomes that would require expert ground truth.

4. Adjudication method for the test set:

This information is not applicable and therefore not provided. The tests are objective engineering measurements (e.g., OD measurement, tensile strength) rather than subjective assessments requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not provided and is not applicable to the type of device and testing described. The Pioneer Plus Catheter is a physical medical device (catheter with ultrasound imaging), not an AI-driven diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not provided and is not applicable. The device is not an algorithm, but a physical catheter. While it incorporates an intravascular ultrasound (IVUS) transducer, the performance evaluation described focuses on the physical integrity and characteristics of the catheter itself, not the standalone performance of an ultrasound imaging algorithm.

7. The type of ground truth used:

The ground truth for the performance tests appears to be known standards or product specifications. The document states, "Bench testing was conducted against known standards or product specification."

8. The sample size for the training set:

This information is not provided. The document describes testing of a physical medical device against engineering specifications. There is no mention of a "training set" as would be relevant for machine learning or AI algorithms.

9. How the ground truth for the training set was established:

This information is not provided as there is no mention of a "training set."

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The Pioneer Plus catheter is intended to facilitate placement and positioning of catheters within the peripheral vasculature. The Pioneer Plus catheter also provides an intraluminal cross-sectional ultrasound image of the area of interest to facilitate placement of guidewires beyond stenotic lesions (e.g., sub-total, total or chronic total occlusions) prior to additional intervention (i.e. PTCA, stent, etc.). The Pioneer Plus catheter is not indicated for use in the coronary or cerebral vasculature.

Percutaneous catheter that utilizes IVUS imaging and a hollow Nitinol needle to facilitate redirection and placement of a 0.014° OTW guidewire into peripheral vessels. The guidewire can then facilitate placement of subsequent devices. The device is a single use, sterile catheter.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Pioneer Plus Catheter:

Summary of Acceptance Criteria and Device Performance (Based solely on the provided text):

The provided 510(k) summary primarily focuses on changes to an existing device (Pioneer Plus Catheter, K081804). As such, it relies on demonstrating that the modified device remains substantially equivalent to its predicate, rather than establishing entirely new performance criteria.

Study Information:

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated. The document mentions "Testing on the needle subassembly," but does not provide details on the number of units tested.
   • Data Provenance: Not explicitly stated. The testing appears to be internal to Medtronic Vascular ("Medtronic Vascular Ms. Lucinda Fox Regulatory Affairs Manager"). It is not specified if the data is from a particular country or if it's retrospective or prospective. Given it's for a "Special 510(k) - Changes Being Effected," it's likely a controlled, prospective internal test of the modified components.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This type of information is not applicable to this submission. The submission is not for an AI/machine learning device that requires expert-established ground truth for its performance evaluation. This is a medical device (catheter) where performance is assessed through engineering testing (e.g., mechanical, functional) and comparison to specifications, not diagnostic accuracy against a ground truth.

3. Adjudication method for the test set:

   • Not applicable. As the performance is based on engineering testing of the modified needle subassembly, there wouldn't be an adjudication method in the context of diagnostic accuracy.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This is not an AI-assisted device, therefore, an MRMC study is not relevant or mentioned.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is a physical medical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Not applicable. For a physical device like this, the "ground truth" for performance is typically engineering specifications, material properties, and functional requirements verified through physical testing, rather than expert consensus on diagnostic interpretations or pathology. The assessment here is about the device's ability to "meet its original specifications" and that process changes "did not negatively affect its performance or functionality."

7. The sample size for the training set:

   • Not applicable. This submission is for a physical medical device, not an AI/machine learning model, so there is no concept of a "training set" in this context.

8. How the ground truth for the training set was established:

   • Not applicable. As there is no training set for an AI model, this question is irrelevant to this submission.

Conclusion from the Document:

This 510(k) is a "Special 510(k) - Changes Being Effected" for the Pioneer Plus Catheter. The primary purpose of the submission is to demonstrate that minor changes (specifically, manufacturing process improvements to the needle subassembly and additions to the Instructions for Use regarding needle retraction failure) do not negatively impact the device's safety or effectiveness and that the device remains substantially equivalent to its cleared predicate. The "study" mentioned is internal "Testing on the needle subassembly" to confirm its performance after the process changes. No details on this testing (e.g., sample size, specific tests, results) are provided beyond the statement that it "confirmed the process changes did not negatively affect its performance or functionality."

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The Pioneer Plus Catheter is intended to facilitate placement and positioning of catheters within the peripheral vasculature. The Pioneer Plus Catheter also provides an intraluminal cross-sectional ultrasound image of the area of interest to facilitate placement of guidewires beyond stenotic lesions (e.g., sub-total, total or chronic total occlusions) prior to additional intervention (i.e. PTCA, stent, etc.). The Pioneer Plus Catheter is not indicated for use in the coronary or cerebral vasculature.

The proposed device is a catheter which utilizes IVUS imaging and a hollow Nitinol needle to facilitate redirection and placement of a 0.014" OTW guidewire into peripheral vessels. The guidewire can then facilitate placement of subsequent devices. The device is a single use, sterile catheter.

The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. Instead, it is a 510(k) summary and FDA clearance letter for a medical device called the "Pioneer Plus Catheter."

The summary primarily focuses on establishing "substantial equivalence" to a predicate device (Pioneer Catheter, K072155) based on:

• Same indications for use: Facilitate placement and positioning of catheters and provide an intraluminal cross-sectional ultrasound image to facilitate guidewire placement beyond stenotic lesions in peripheral vasculature (not coronary or cerebral).
• Substantially equivalent performance, function, and device characteristics.
• Non-clinical data: In vitro and in vivo testing were completed to assess substantial equivalence in terms of indications, performance, function, device characteristics, materials, packaging, biocompatibility, sterilization, and stability.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study details as this type of information is not present in the provided document.

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